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Effectiveness of Messages to Mobile Phone in Smoke Cessation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01746069
First Posted: December 10, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Raquel Cobos Campos, Basque Health Service
  Purpose

Smoking remains a major risk factor for chronic diseases and is a real problem for health systems. The use of emerging technologies, such as mobile phone , may have a important role in smoking cessation programs through sending reinforcement messages when patients quits smoking.

Main objective: To evaluate the effectiveness of a combined 6 months smoking cessation program including health advice provided by a doctor and sending support messages to mobile phone of patients.

Methods: Study design: Randomized single blind clinical trial. Study population: Patients over 18 who are willing to start a smoking cessation program, who have mobile phone, who are able to receive and send messages, and who have a score greater than 5 or equal to 5 on the Richmond scale.

Sample size: 160 patients per arm to detect a difference in the percentage of smoking cessation than 10% (14.9% vs. 4.9%) between the two groups. Intervention: Experimental group: Health advice and support messages to mobile phone patients.

Control group: Health advice. Assessment of the primary endpoint: At 6 months (positive/negative coximetry test).

Statistical analysis: The analysis of the primary endpoint (positive / negative coximetry test) will be performed using logistic regression.


Condition Intervention
Smoking Behavioral: Quit smoking combined cessation programme Behavioral: health advice

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of a Reinforcement Program Using Text Messages Through Mobile Phone in Smoking Cessation Programs in Primary Care

Resource links provided by NLM:


Further study details as provided by Raquel Cobos Campos, Basque Health Service:

Primary Outcome Measures:
  • Coximetry test (positive/negative) [ Time Frame: at 6 months ]

Secondary Outcome Measures:
  • Continuous abstinence at 6 months: Yes / No [ Time Frame: At 6 months ]
    Continuous Abstinence is defined as smoking more than 5 cigarettes since the beginning of the follow-up period self-reported by the patient.

  • Abstinence point during the first 7 days self-reported by the patient: Yes / No. [ Time Frame: at first week ]
    Abstinence is defined as not smoking anything punctual during the last seven days.

  • -Prevalence abstinence at the 4th week self-reported by the patient: Yes / No. [ Time Frame: At 4th week ]
  • -Prevalence abstinence at 12th week self-reported by the patient: Yes / No. [ Time Frame: At 12th week ]
  • -Outcome of coxymetry test at 12 months of start: Positive / Negative. [ Time Frame: at 12 months ]
    Only in patients with a negative result in the 6 months test

  • Number of messages requested by the patient anxiety. [ Time Frame: at 12 months ]
  • slip: Yes / No. [ Time Frame: at 12 months ]
    Treated as the first use (consumption point) after a period of abstinence

  • - Relapse: Yes / No. [ Time Frame: At 12 months ]
    Relapse is defined to return dependent behavior that had tried to change, recovering or not the baseline levels before treatment.

  • Number of messages relapse-slip timely requested by the patient. [ Time Frame: At 12 months ]

Other Outcome Measures:
  • other variables [ Time Frame: at baseline ]
    Sex (male / female), age (years), number of cigarettes per day before starting program, age of start smoking (years), smoke related pathology (Yes/No), score on the anxiety scale Goldberg, previous attempts to quit smoking (Yes / No if yes, specify number of attempts and reasons for relapse), ), smoking dependence fagerström test score), type of smoker (occasional / daily).


Enrollment: 320
Study Start Date: March 2013
Study Completion Date: October 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: health advice
clinical practice routine
Behavioral: health advice
routine clinical practice
Experimental: Quit smoking combined cessation programme
Health advice and support sms messages to patient's mobile phone + clinical routine practice
Behavioral: Quit smoking combined cessation programme
Support sms messages to patient's mobile phone and health advice

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 18 years.
  • Current smoker (25): Current smoker is defined as the person who at the time of the study beginning declares that smoked daily or occasionally.
  • Possessing mobile phone.
  • Able to receive and send messages through mobile phone.
  • Score greater than 5 or equal to 5 on the Richmond scale

Exclusion criteria:

  • People with a history of mental and behavioral disorders.
  • Patients with a diagnosis of depression using the depression subscale of Goldberg (two or more positive responses).
  • Patients who with pharmacological therapy for smoking cessation or who require it throughout the study.
  • Pregnant women.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746069


Locations
Spain
Health centre Lakuabizkarra
Vitoria-Gasteiz, Alava, Spain, 01009
Sponsors and Collaborators
Basque Health Service
  More Information

Responsible Party: Raquel Cobos Campos, pharmaceutical, Basque Health Service
ClinicalTrials.gov Identifier: NCT01746069     History of Changes
Other Study ID Numbers: TAB-01
First Submitted: December 7, 2012
First Posted: December 10, 2012
Last Update Posted: October 12, 2017
Last Verified: October 2015

Keywords provided by Raquel Cobos Campos, Basque Health Service:
smoking
smoke cessation
sms
quit smoke